Abstract: This disclosure relates generally to prosthetic valves and methods and systems for deploying, positioning, and recapturing the same. A prosthetic valve includes one or more support structures. At least one of the one or more support structures defines an elongate central passageway of the prosthetic valve. The prosthetic valve can also include a plurality of leaflet elements attached to at least one of the one or more support structures and disposed within the elongate central passageway for control of fluid flow through the elongate central passageway. At least one of the one or more support structures is configured to biodynamically fix the prosthetic valve within a native valve such as, for example, a native tricuspid valve of a heart.

Abstract: Disclosed herein are embodiments of an expandable replacement heart valve prosthesis. The expandable replacement heart valve prosthesis can include a number of different features, such as an hourglass (or generally hourglass) shape in the fully expanded position, anchor stiffening features, and improved retraction/retention configurations. For example, certain struts on the prosthesis can have different thicknesses/widths than other struts to improve compressibility.

Abstract: Devices, systems and methods are described herein to provide improved steerability for delivering a prosthesis to a body location, for example, for delivering a replacement mitral valve to a native mitral valve location. Disclosed are a number of features that can improve steerability or release of the prosthesis into the body location.

Abstract: Methods for delivering a replacement heart valve include advancing a delivery system through a femoral vein and into the atrium of a heart, wherein the delivery system includes an outer sheath assembly, a mid shaft assembly and an inner assembly. The outer sheath assembly and the mid shaft assembly are adapted to retain the replacement heart valve in a radially compacted state over the inner assembly. The outer sheath assembly is retracted to allow a plurality of distal anchors to self-expand while a portion of the replacement heart valve remains retained in a compacted state by the mid shaft assembly. The distal anchors are positioned to engage one or more native leaflets and the retained portion of the replacement heart valve is then released and allowed to fully expand for implanting the replacement heart valve within the native valve.

Abstract: A mitral valve prosthesis includes an hourglass shaped inner frame and a bulbous outer frame. A valve body having a plurality of leaflets is positioned within an interior region of the inner frame. The leaflets are shaped to substantially conform to an interior surface of the inner frame when the leaflets are in an open position. As a result, the gap between the leaflets and the inner frame is decreased, thereby reducing the likelihood of thrombus formation. Ventricular anchors are preferably provided along a distal end of the inner frame. The anchors extend proximally for placement behind native mitral valve leaflets. A fabric skirt may extend along an inner or outer surface of the outer frame. In preferred embodiments, the fabric skirt extends distally beyond a distal end of the outer frame and is adapted for forming a seal along the mitral valve annulus.

Abstract: A prosthesis for placement within a native mitral valve includes an expandable frame having locking tabs disposed along a proximal end. A plurality of distal anchors are disposed along a distal end of the frame. Each distal anchor is provided with a cushion cover. An outer fabric member surrounds the frame and may extend outwardly from the frame in an expanded condition for providing an improved seal in the region of a mitral annulus. A valve body is positioned within an interior of the expandable from for allowing blood flow in only one direction. In preferred embodiments, the cushions are positioned over enlarged head portions of the distal anchors for further reducing trauma on surrounding tissue.

Abstract: A system for implanting a replacement heart valve at a native valve location between an atrium and a ventricle of a patient includes a replacement valve having an expandable frame and a plurality of prosthetic valve leaflets positioned within the expandable frame. A delivery device is provided for delivering the replacement heart valve to the native valve location. The delivery device includes an elongate inner tube having an inner retention ring for coupling to and end of the replacement heart valve and an outer support tube slidable over the inner retention ring for securing the replacement heart valve to the inner retention ring. The inner retention ring preferably includes slots for receiving struts of the expandable frame. The expandable frame preferably includes a plurality of anchors extending from the downstream portion in an upstream direction for extending between chordae and for placement outside of the native leaflets.

Abstract: Devices, systems and methods are described herein a prosthesis for implantation within a lumen or body cavity and delivery devices for delivering the prosthesis to a location for implantation. A delivery system can include a plurality of components which are moveable relative to each other. The delivery system can include a nose cone which can cover at least a first end of the prosthesis, an outer elongate member which can cover at least a second end of the prosthesis, and a tether which can at least partially restrain the prosthesis from deployment.

Abstract: A system for treating aortic dissection including an aortic dissection implant comprising an expandable anchoring structure and an elongate tubular structure. The expandable anchoring structure can be configured to apply radial force to the sinuses of the aortic root and/or the sinotubular junction when expanded. The elongate tubular structure can comprise an expandable support frame and one or more layers. The expandable support frame can be configured to extend from the descending aorta to the ascending aorta and curve along with a curvature of the aortic arch when expanded within the aorta. The one or more layers can comprise a first porous layer comprising an atraumatic outer surface positioned over the expandable support frame and a second non-porous layer positioned over a portion of the first porous layer. The second non-porous layer may be configured to be positioned on opposite sides of the aortic dissection and to be inflatable via blood flow to seal against the dissection.

Abstract: A system for treating atrial dysfunction, including heart failure and/or atrial fibrillation, that includes one or more pressurizing elements and control circuitry. The one or more pressurizing elements can comprise one or more balloons and can be configured to be positioned in the left atrium, and optionally the pulmonary artery, of a patient's heart. The one or more pressurizing elements can be coupled to one or more positioning structures that can be configured to position the one or more pressurizing elements in the left atrium, and optionally the pulmonary artery. The control circuitry can be configured to operate the one or more pressurizing elements to decrease or increase pressure and/or volume in the left atrium, and optionally the pulmonary artery, in accordance with different phases of the cardiac cycle.

Abstract: A replacement heart valve and method of treating valve insufficiency includes an expandable frame configured to engage a native valve annulus. A valve body is coupled to the frame. The valve body can include a leaflet portion and possibly a skirt portion. A portion of the frame has a foreshortening portion configured to longitudinally expand when urged to a radially compacted state and longitudinally contract when urged to a radially expanded state. In one embodiment the valve skirt is attached to the frame so that it can adapt to changes in the length of the frame. A delivery device in some embodiments can use one or more coverings, such as sheaths, to controllably release the replacement heart valve at a native heart valve.

Abstract: A mitral valve prosthesis includes an expandable frame having a proximal end, a distal end, and a middle portion. A plurality of tips extends from the proximal end of the frame for attachment to a delivery catheter. A plurality of anchors is disposed along the distal end of the frame and extend toward the proximal end for engaging tissue. An outer circumferential portion extends around the middle portion of the frame and is positioned radially outwardly of the frame. The outer circumferential portion preferably increases in diameter along a distal direction. A distal end of the outer circumferential portion is located distal of free ends of the anchors when the expandable frame is deployed. A valve body is positioned within an interior of the expandable frame and includes leaflets adapted to allow flow in a first direction and prevent flow in a second direction.

Abstract: Methods are described herein for delivering a replacement valve to a native valve location. In one method, ventricular anchors of the replacement valve are released and allowed to reverse orientation while positioned in the atrium of a human heart. After reversing orientation, the ventricular anchors extend in a generally proximal direction. The ventricular anchors can then be advanced through the annulus into the ventricle and then moved back toward the atrium to capture native valve leaflets between the main body and the ventricular anchors of the replacement valve. In one modification, the ventricular anchors are allowed to reverse orientation at a level adjacent the annulus. The implantation methods described herein are preferably performed via a transseptal delivery approach or a transapical delivery approach.

Abstract: A replacement heart valve has an expandable frame configured to engage a native valve annulus and a valve body mounted to the expandable frame. The valve body can have a plurality of valve leaflets configured to open to allow flow in a first direction and engage one another so as to close and prevent flow in a second direction, the second direction being opposite the first direction.

Abstract: A prosthesis can comprise an expandable frame, a plurality of distal anchors and a plurality of proximal anchors. The anchors can extend outwardly from the frame. The frame can be configured to radially expand and contract for deployment within a body cavity. The frame and anchors can have one of many different shapes and configurations. For example, when the frame is in an expanded configuration, the proximal anchors can extend a significant distance away from the exterior of the frame, such as a length equal to or greater than about one half the diameter of the frame. As another example, the anchors can have looped ends.

Abstract: This disclosure relates generally to prosthetic valves and methods and systems for deploying, positioning, and recapturing the same. A prosthetic valve includes one or more support structures. At least one of the one or more support structures defines an elongate central passageway of the prosthetic valve. The prosthetic valve can also include a plurality of leaflet elements attached to at least one of the one or more support structures and disposed within the elongate central passageway for control of fluid flow through the elongate central passageway. At least one of the one or more support structures is configured to biodynamically fix the prosthetic valve within a native valve such as, for example, a native tricuspid valve of a heart.

Abstract: A system for treating aortic dissection including an aortic dissection implant comprising an expandable anchoring structure and an elongate tubular structure. The expandable anchoring structure can be configured to apply radial force to the sinuses of the aortic root and/or the sinotubular junction when expanded. The elongate tubular structure can comprise an expandable support frame and one or more layers. The expandable support frame can be configured to extend from the descending aorta to the ascending aorta and curve along with a curvature of the aortic arch when expanded within the aorta. The one or more layers can comprise a first porous layer comprising an atraumatic outer surface positioned over the expandable support frame and a second non-porous layer positioned over a portion of the first porous layer. The second non-porous layer may be configured to be positioned on opposite sides of the aortic dissection and to be inflatable via blood flow to seal against the dissection.

Abstract: A replacement mitral valve prosthesis includes a support structure and a valve body having three flexible leaflets. The support structure preferably includes an internal valve frame and an external sealing frame. The valve frame supports the flexible leaflets. The sealing frame is adapted to conform to the shape of the native mitral valve annulus. The sealing frame may be coupled to an inlet end of the valve frame, an outlet end of the valve frame, or both. A plurality of anchors is coupled to the outlet end of the valve frame. The anchors extend radially outwardly for placement behind native leaflets. The prosthesis preferably includes a skirt disposed along an exterior of the external sealing frame. The prosthesis is collapsible for delivery into the heart via a delivery catheter. The prosthesis is configured to self-expand for deployment in the heart when released from the delivery catheter.

Abstract: A method of treating a diseased native valve includes advancing a replacement heart valve to native valve annulus. The heart valve includes an expandable frame and a valve body. The frame is formed with a plurality of cells and the valve body is formed with a plurality of leaflets configured to allow blood flow in a first direction. The frame is expanded from a radially compacted configuration to an expanded configuration at the native valve annulus. The replacement heart valve also includes one or more openings covered by one or more flaps and blood is allowed to flow through the openings in the first direction.

Abstract: A mitral valve prosthesis includes an expandable frame having a proximal end, a distal end, and a middle portion. A plurality of tips extend from the proximal end of the frame for attachment to a delivery catheter. A plurality of anchors are disposed along the distal end of the frame and extend toward the proximal end for engaging tissue. An outer circumferential portion extends around the middle portion of the frame and is positioned radially outwardly of the frame. The outer circumferential portion preferably increases in diameter along a distal direction. A distal end of the outer circumferential portion is located distal of free ends of the anchors when the expandable frame is deployed. A valve body is positioned within an interior of the expandable frame and includes leaflets adapted to allow flow in a first direction and prevent flow in a second direction.